Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06813339




Registration number
NCT06813339
Ethics application status
Date submitted
13/01/2025
Date registered
6/02/2025
Date last updated
10/02/2025

Titles & IDs
Public title
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
Scientific title
A Double Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
Secondary ID [1] 0 0
CTx-001
Universal Trial Number (UTN)
Trial acronym
CTx-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Acute Coronary Syndromes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UDP-003
Other interventions - Placebo

Experimental: UDP-003 - UDP-003 will be administered to the participants randomised to this arm. UDP-003 is a formulated as a sterile solution for injection, 300 mg/mL. Volume of administration is weight dependent and target doses are 1-25 mg/kg.

Placebo comparator: Placebo - Placebo will be administered to the participants randomised to this arm. Placebo formulated as sterile solution for injection. Volume injected will match the volumes of UDP-003 for each panel and each participant.


Treatment: Drugs: UDP-003
The UDP-003 finished product is clear, colourless to yellow liquid that is intended to be a sterile solution for IV bolus push administration in sterile water at a concentration of 300 mg/mL.

Other interventions: Placebo
Placebo will be provided as a sterile clear, colourless solution formulated to match viscosity of the UDP-003 solution.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety outcome measures (Adverse Events)
Timepoint [1] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [2] 0 0
Safety outcome measures (Vital Signs: Systolic Blood Pressure)
Timepoint [2] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [3] 0 0
Safety outcome measures (Vital Signs: Diastolic Blood Pressure)
Timepoint [3] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [4] 0 0
Safety outcome measures (Vital signs: Heart Rate)
Timepoint [4] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [5] 0 0
Safety outcome measures (Vital signs: Respiratory Rate)
Timepoint [5] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [6] 0 0
Safety outcome measures (Vital signs: Temperature)
Timepoint [6] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [7] 0 0
Safety outcome measures (Clinical Laboratory Parameters)
Timepoint [7] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [8] 0 0
Safety outcome measures (ECG QTCF Interval)
Timepoint [8] 0 0
From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [9] 0 0
Safety outcome measures (Injection site reactions)
Timepoint [9] 0 0
From first dose administration (Day 1) through From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Primary outcome [10] 0 0
Safety outcome measures (Audiometry: PTA)
Timepoint [10] 0 0
From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Primary outcome [11] 0 0
Safety outcome measures (Audiometry: HFA)
Timepoint [11] 0 0
From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Primary outcome [12] 0 0
Safety outcome measures (Audiometry: Self-evaluation questionnaire (THI))
Timepoint [12] 0 0
From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Primary outcome [13] 0 0
Safety outcome measures (Audiometry: Self-evaluation questionnaire (DHI))
Timepoint [13] 0 0
From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Secondary outcome [1] 0 0
Pharmacokinetics Outcome Measures (Cmax)
Timepoint [1] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Secondary outcome [2] 0 0
Pharmacokinetics Outcome Measures (Tmax)
Timepoint [2] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Secondary outcome [3] 0 0
Pharmacokinetics Outcome Measures (half-life (t1/2))
Timepoint [3] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Secondary outcome [4] 0 0
Pharmacokinetics Outcome Measures (AUC0-t and AUC0-inf)
Timepoint [4] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Secondary outcome [5] 0 0
Pharmacokinetics Outcome Measures (Total Plasma Clearance (CL))
Timepoint [5] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Secondary outcome [6] 0 0
Pharmacokinetics Outcome Measures (Volume of Distribution (Vd))
Timepoint [6] 0 0
Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

Eligibility
Key inclusion criteria
(Healthy Participants (SAD and MAD cohorts)):

* Healthy adult males and females, 18 to 45 years of age (inclusive) at the time of screening.
* Medically healthy with relevant renal parameters tests not exceeding the upper limits and no clinically significant screening results (e.g., laboratory profiles, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator.

(Participants with ACS (MD Patient cohort):

* Adult males and females, 40 to 59 years of age (inclusive) at the time of screening, diagnosed with acute coronary syndrome (ACS), at least 12 months post event (NSTEMI or unstable angina).
* Medically stable with no clinically significant screening results (e.g., laboratory profiles including relevant renal parameters and liver function tests, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator.
* Participants on a stable regimen and dose of ACS treatment including statins, anticoagulants, blood thinners, anti-platelets or other standard of care for 3 months prior to screening and for whom no change in this treatment is planned during the participation in the study.
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(Healthy Participants (SAD and MAD cohorts)):

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as deemed by the Principal Investigator.
* History of myocardial infarction (MI), transient ischemic attack (TIA), stroke, or familial history of coronary artery disease or first-degree heart attack below the age of 60.
* Any clinically significant ECG abnormality at Screening
* Diabetic participants

(Patients (MD cohort):

* Percutaneous coronary intervention or diagnostic angiogram planned after screening.
* Documented episode of post-MI pericarditis in the 3 months before enrollment.
* Ongoing heart failure as defined by Class IV New York Heart Association
* History or presence of significant pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Ongoing infection or febrile illness.
* Ongoing atrial fibrillation or flutter.
* History of MI, TIA, or stroke diagnosed within the 12 months prior to screening.
* History of or planned coronary artery bypass grafting.
* Any cardiac intervention or cardiac hospitalization in the past 12 months
* Any clinically significant ECG abnormality at Screening.
* Participants with contraindications to CTA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
6/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cyclarity Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)/pharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its potential efficacy in patients.

Researchers will compare UDP-003 to a placebo in a blinded manner.

This first in human, randomised, double-blind, placebo-controlled, prospective, single-centre trial with a modular dose-finding design will be conducted in 3 parts:

* Part 1: 6 cohorts of 6 healthy participants receiving Single Ascending Doses (SADs),
* Part 2: 3 cohorts of 12 healthy participants receiving Multiple Ascending Doses (MADs) (6 doses over 16 days),
* Part 3: 1 cohort of 12 participants diagnosed with acute coronary syndrome (ACS; non-ST elevation myocardial infarction \[NSTEMI\] or unstable angina) at least 12 months post-event receiving multiple doses (6 administrations of the 25 mg/kg dose over 16 days).

The planned duration of the study for each participant will be:

* 4 weeks for SAD Participants (1-day treatment period, 4-week safety follow-up)
* 6 weeks for MAD Participants (16-day treatment period,4-week safety follow-up)
* 28 weeks for MD Patients (16-day treatment period, 6-month safety follow-up) Prior to participants being randomised to panels of increasing doses, all safety data will be reviewed for completed panels.
Trial website
https://clinicaltrials.gov/study/NCT06813339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel M Clemens, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
(707) 200-3610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06813339